Global MLR Expansion

Prior to this Release:

  • United States was the only available Country for MLR routing in PromoMats Basics.

Starting in 26R1:

The following new Country values can now be used for MLR routing:

  • Global
  • France
  • United Kingdom
  • Spain
  • Italy

In PromoMats Basics, the lifecycle that a document will follow depends on the input for the Country and Product Type fields, and whether or not the Approved with Changes Country Setting has been enabled by a Vault or PromoMats Admin. To accommodate all relevant regulations, additional workflows and roles are available based on these selections.

Note Regardless of the input for the above fields, each task will follow the same general process outlined in Review a Document and Approve a Document, but the specific task text varies based on the document’s Country.

United States

The document lifecycle for United States has the following defining features:

Optional Review
Users can bypass the Review workflow in favor of Approvals.
Device Products
Health authority submission fields and workflows are hidden, ad hoc reviewers have additional options in the Capacity field.
Drug Products
Utilize the Submit to FDA workflow after MLR approvals.
Approved with Changes
An admin can enable the Approve with Changes Country Setting, allowing the Approved with Changes Workflow Action during approvals.

Global, Italy, & Spain

The document lifecycle for Global, Italy, & Spain has the following defining features:

Optional Review
Users can bypass the Review workflow in favor of Approvals.
Device Products
Health authority submission fields and workflows are hidden, ad hoc reviewers have additional options in the Capacity field.
Drug Products
Utilize the relevant health authority in the “Submit to…” workflow following MLR approvals.
Approved with Changes
An admin can enable the Approve with Changes Country Setting, allowing the Approved with Changes verdict during the approval workflow.

France

The document lifecycle for France has the following defining features:

Optional Review
Users can bypass the Review workflow in favor of Approvals.
Drug Products
Utilize the Final Release approval workflow featuring the Responsible Pharmacist role as the final approver.
Device Products
Utilize the same Final Release approval workflow, featuring the Person Responsible for Regulatory Compliance (i.e. a Regulatory user) as the final approver.
Approved with Changes
An admin can enable the Approve with Changes Country Setting, allowing the Approved with Changes Workflow Action during approvals.

United Kingdom

The document lifecycle for the United Kingdom has the following defining features:

Media Field
A required field on United Kingdom documents that states whether the final form of the material will be in print or digital format.
Drug Products
  • Utilize the Certification approval workflow for documents that require Medical Signatory and/or Appropriately Qualified Person (AQP) approval.
  • If the Media field is set to Print, the Review Physical Copy workflow should take place after Certification.
  • Utilize the Examination approval workflow for low-risk documents, where the approvers are traditional Medical, Legal, and Regulatory users.
Device Products
Follow a conventional MLR process with Medical, Legal, and Regulatory users providing review and approval.
Approved with Changes
An admin can enable the Approve with Changes Country Setting, allowing the Approved with Changes verdict during the approval workflow for Device Products (does not apply to Certification and Examination).